Recruiting

Trikafta

Sponsor:

University of British Columbia

Code:

NCT05279040

Conditions

Cystic Fibrosis

Lung Diseases

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Trikafta

Study Details

Brief summary:

Shortness of breath (dyspnea) during exercise is a major source of distress and is a commonly reported symptom in patients with cystic fibrosis (CF). A recent drug treatment option known as Trikafta, which contains elexacaftor, tezacaftor, and ivacaftor, may be used in patients with CF to help improve lung health. However, the effects of this combination therapy on dyspnea and exercise performance, a known predictor of survival in CF, are not clear. The investigators aim to understand the effects of Trikafta on these symptoms and to gain new insight into the potential health improvements in CF from using this treatment option.

Conditions

Cystic Fibrosis

Lung Diseases

Study ID

NCT05279040

Start date

Nov 10, 2021

Status verified date

May, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Confirmed diagnosis of CF and at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
  • Plan to initiate Trikafta by the treating physician within 30 days of the enrolment visit
  • Aged 19 years or older
  • Stable clinical status based on clinical judgment of the treating physician
  • Forced Expiratory Volume in 1 second (FEV1.0) < 90% predicted
  • Body mass index greater than 16 or less than 30 kg/m\^2
  • Currently non-smoking or a past smoking history of less than 20 pack-years
  • Able to read and understand English
  • Fully vaccinated (at least 2 doses) for Covid-19

Exclusion Criteria:

  • A disease other than CF that could importantly contribute to dyspnea or exercise limitation
  • Chronic airway infection with Mycobacterium abscessus, Burkholderia cepacia complex, or other organisms with infection control implications based on the treating physicians
  • Contraindications to clinical exercise testing
  • Use of supplemental oxygen or desaturation less than 85% with exercise
  • Diagnosis of pneumothorax in the past 4 weeks
  • History of organ transplantation

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Cystic Fibrosis Patients

Participants diagnosed with cystic fibrosis who will be initiating Trikafta treatment

Interventions

Trikafta

Elexacaftor/Tezacaftor/Ivacaftor combination therapy

Primary outcome measure

  • Change in Iso-time Dyspnea Rating From Baseline (Visit 2) to Visit 3 and 4 During Constant-load Exercise Tests. [ Time Frame: Baseline (i.e., Visit 2), 12 months post Trikafta initiation (i.e., Visit 3), and 24 months post Trikafta initiation (i.e., Visit 4) ]

Central Contacts and Locations

Central contacts

Satvir S Dhillon, MSc

6048068835satvir.dhillon@hli.ubc.ca

Jordan Guenette, PhD

16048068835jordan.guenette@hli.ubc.ca

Locations

UBC Centre for Heart Lung Innovation, St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Satvir S Dhillon

6048068835satvir.dhillon@hli.ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Dyspnea
  • Exercise
  • Trikafta

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-18.